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BioSpace

Director, AI/ML Pharmaceutical Manufacturing Innovation

BioSpace, Rockville, Maryland, us, 20849

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Director, AI/ML Pharmaceutical Manufacturing Innovation

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. Description USP believes that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide. USP values inclusive scientific collaboration and recognizes that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Brief Job Overview The USP Advanced Manufacturing Technologies (AMT) team seeks to continuously move medicine manufacturing into the future through practical applications and solutions in advanced manufacturing and analytical technologies that increase medicine quality and strengthen supply chain resiliency. The Director for AI/ML Innovation in Pharmaceutical Manufacturing will define and execute a multi-year strategic roadmap for delivering AI/ML-powered services and solutions to pharmaceutical manufacturers, government agencies, and other funders. Responsibilities Develop and execute a strategic roadmap for AI/ML services and solutions for USP's AMT program. Engage externally to understand the needs and challenges of industry, donors, and government stakeholders as it relates to application of AI/ML in pharmaceutical manufacturing. Build and maintain relationships with key partners and clients, focusing on long-term collaborations that drive the effective use of AI/ML in pharmaceutical manufacturing and supply chain solutions. In collaboration with the Federal Practice and Business Development teams, develop winning proposals that deliver value to key accounts or offset the costs of USP's internal projects. Lead the execution of detailed, AI/ML aspects of workplans on both client projects and internal development initiatives. Actively be a key opinion leader for AI/ML in pharmaceutical manufacturing in workshops, fora, conferences, white papers, journal articles, and other outlets. Provide subject matter expertise on use of AI/ML applications in the work of the AMT program as well as the broader work of the Global Health and Manufacturing Services division. Collaborate with the Digital and Information Division and the Science and Standards Division in USP on the role AI/ML plays in the future of pharmaceutical manufacturing, quality paradigms, and supply chain solutions. Generate valuable insights into the technical, financial, and regulatory return on investment for leveraging AI/ML in pharmaceutical manufacturing processes. Support AMT's development roadmap through 2030 by identifying and developing AI/ML models and programs that can be used in continuous manufacturing, additive manufacturing, and spectroscopy-based quality testing and control systems. Requirements Bachelor's degree and twelve (12) years of related experience; master's degree and seven (7) years of related experience; or Ph.D. (or equivalent advanced degree) and three (3) years of related experience. In-depth experience with digital, data, and analytics techniques in the pharmaceutical industry. Demonstrated experience applying AI/ML to complex systems as well as developing or applying techniques such as pre-processing, classification, regression, clustering, dimensionality reduction and model selection. Strong critical thinking and business acumen. Communications skills both written and oral. Demonstrates initiative to solve problems; effective at making and implementing decisions. Desire to affect change and drive public health impact. Willingness to travel up to 10% as needed. USP is an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds to contribute to advancing public health solutions worldwide. Benefits USP provides benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected. Compensation Base Salary Range: $160,700.00 - $213,700.00 annually.

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